A primary endpoint for ONCY'S Phase 2 metastatic breast cancer (Bracelet-1) of overall survival (OS) has been maturing and the 2 year data timeline was reached at the end of May- early June 2024. Now that the important and statistically significant FDA 2 year OS milestone has been met, I think that ONCY may have decided to lengthen the OS time period by extending the data collection cutoff date.
The effect of having extended data on OS should make for even more ccompelling request for an FDA Accelerated Approval for pelareorep (monotherapy) + paclitaxel in mBC.
And with two Phase 2 clinical trials completed, in metastatic breast cancer, namely IND-213 and Bracelet-1, and a PFS, ORR and mOS reported in Bracelet-1 of 38.2%, 37.5% and a near doubling in median overall survival, respectively, ONCY is the closest to an Accelerated Approval than any other agent in this category of immunomodulators.
Mature overall survival (OS) from the Bracelet-1 study is expected at anytime.which supports an Accelerated Approval request, now that ONCY has guided on a planned adaptive 180-200 patient Phase 2b/ Phase 3/confirmatory clinical trial, that can morph from one Phase to another as an adaptive design provides, and which ONCY is able to conduct on its own.
This notwithstanding ONCY has committed to releasing the mature OS mBC data in H2 2024 ... which can be anytime now. - making reference in the release perhaos, that OS is still maturing but that the current 2 year + OS data has met the mature survival timeline sufficient for the FDA to grant an Accelerated Approval for pelareorep in mBC.